Chetan Pingale Email and Phone Number

Production QMS

1) Working on Human Insulin and Insulin Glargine ( rDNA Origin) yeast based.2) Working on Recombinant Trypsin and Carboxy Peptidase (CPB) production ( Recombinant DNA Technology).3) Handling Cell-Separation by Centrifugation, Micro-filtration, Ultra-filtration, Depth-Filtration operations and Pre treatment reactions.

1) Worked on Human Insulin and It's analogues like Insulin Glargine, Aspart and clinical trail phase of Lispro. (Bacterial culture E.coli Based)2) Handled old production facility renovation and new production facility project work.3) New facility Equipment's and Instrument's Installation Qualification, Operational Qualification and Performance Qualification.4) HVAC (Heating Ventilation Air Conditioning) and Water system Qualification and its Validation.5) New SOP's (Standard Operating Procedure) and BMR's (Batch Manufacturing Records) Preparation.6) Handled QMS ( Quality Management System) Work like Change Control, Deviation, Investigation report, CAPA (Corrective And Preventive Action), Protocol and Report preparation.7) Hands on experience of Fermenters of capacity 2 L to 2 KL, Homogeniser, Micro Filtration, Centrifugation system.8) Handled Solubilisation and Refolding reactions.

Worked in In-Process Quality Assurance (IPQA) department.Learned all basics of Quality Assurance Department.

Worked on Bio-Fertilizers, Bio-Insecticides, Bio-Pesticide production by Bacterial and Fungal strainsstrains.Maintaining and Sub-culturing of Bacterial and fungal strains.Soil testing to identify the amount of Macro and Micro nutrients present in soil.